[Ip-health] Wall Street Journal: Generic-Drug Approvals Soar, But Patients Still Go Without

Thiru Balasubramaniam thiru at keionline.org
Tue Nov 19 22:08:44 PST 2019



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Generic-Drug Approvals Soar, But Patients Still Go WithoutBrand-name
makers’ patent action limits release of the lower-price medicines,
hindering cost-control efforts
Jared S. Hopkins
Nov. 19, 2019 4:20 pm ET

Record numbers of generic drugs for cancer, heart ailments and other
conditions have received U.S. approval in recent years, raising hopes that
the new competition would reduce high drug costs. But many of the
lower-price medicines haven’t hit the market, a Wall Street Journal review

The result: Many patients are forced to take high-price medicines, and a
widely touted remedy for reining in drug costs has failed to live up to its

Drug-industry officials and other researchers say delays in releasing
generic drugs sometimes stem from businesses changing their strategies. But
they mostly blame protracted legal tie-ups, such as brand-name drugmakers
aggressively defending their products by filing additional patents and
suing generic-drug companies.

In January, five drugmakers received permission from U.S. health regulators
to sell a generic version of antipsychotic drug Latuda. Pharmacists and
patients welcomed the decision because the drug’s list price has tripled to
nearly $1,223 since it was launched eight years earlier. Eleven months
later, none of the companies are selling a lower-price copy.

Since 2016, the Food and Drug Administration has approved 2,492 generic
versions of 617 brand-name drugs, according to health-data firm Iqvia. The
approvals picked up after the agency began its effort in 2017 to address
popular outrage with high drug prices
speeding the review of generic-drug applications.

The number of generic approvals has set records each of the past three
fiscal years, according to the Trump administration. Officials have touted
the efforts, saying that by bringing competition to the market, drug costs
would fall. Generic competition reduces the price of branded drugs by an
average of 39% of any branded drug with four copycats, according to an FDA

But less than two-thirds of generic drugs approved between 2016 and 2018,
or 1,249 of the copies, were launched into the market, according to Iqvia.
Through June, just 30%—or 134—of the 442 approvals this year have gone on
sale. Roughly 40% of last year’s 689 approvals haven’t been launched. (The
approvals may include more than one generic for the same molecule.)

The breakdown is especially acute for the most expensive medicines,
so-called biologic drugs for ailments such as cancer and rheumatoid
often list for hundreds of thousands of dollars a year. Copies of these
, known as biosimilars
are also being launched less frequently. Only 11 products are available
commercially, despite more than two dozen approvals since 2015, the
Journal’s review found.

“It’s very troublesome,” said Ameet Sarpatwari, an instructor at Harvard
Medical School whose research includes pharmaceutical regulation. “Prompt
generic entry is the one known solution to lowering drug prices.”
An FDA spokesman said the agency’s efforts to expedite the approval process
has resulted in a better overall generic program, and it will continue to
work toward creating a competitive market. He said the agency is encouraged
by a “strong pipeline” of applications, but added that companies decide
whether to ultimately launch products.

Pharmacists, generic-industry officials and other researchers cite several
reasons for the lack of generic launches, including generic drugmakers
deciding the potential return isn’t as lucrative as initially thought.
Sometimes their plants aren’t ready to make the drugs, either. Meanwhile,
consolidation among generic drugmakers has sharply cut the number of
companies willing to sell the copies.

The biggest factors, many of the generic-drug experts say, are the legal
defenses mounted by brand-name drugmakers. They have sought to keep
generics away by adding patents to products, while suing generic drugmakers
for allegedly infringing the patents.

The Federal Trade Commission, which tracks patent settlements annually,
issued a report in May that found fewer of those agreements are likely to
be anticompetitive, even though settlements are increasing overall. The FTC
declined to comment on the broader issue.

Most drug-patent disputes in recent years haven’t been over patents for
medicines’ active ingredients, but over what are known as secondary patents
that cover a drug’s formulation or delivery, studies have found.

Two biosimilars of the biologic drug Enbrel that were approved by the FDA
haven’t been launched, including one from Swiss drugmaker Novartis
<https://quotes.wsj.com/NVS> AG that the health agency approved in
drug companies are playing “patent games to protect profits and prevent
competition,” said Chip Davis, chief executive of the generic-drug
industry’s trade group, the Association for Accessible Medicines.

More than 40 patents have protected Enbrel, a rheumatoid-arthritis
treatment. Enbrel’s maker, Amgen <https://quotes.wsj.com/AMGN> Inc., won a
court ruling in August related to Enbrel patents, which Novartis is

Amgen said that protecting its intellectual property helps encourage
innovation. Enbrel, which went on sale in the U.S. in 1998, notched $4.8
billion in sales in the country last year. Amgen prices a year’s supply of
Enbrel’s 50-milligram dose at more than $67,000.

Belgian drugmaker UCB <https://quotes.wsj.com/BE/XBRU/UCB> SA has held off
on the launch of at least seven generic versions of its epilepsy drug
Vimpat after winning patent-infringement lawsuits. Vimpat, which lists for
more than $950 a month, generated $1 billion in global sales for UCB last
year. The FDA approved the first generic version in 2016.

UCB said that patients with insurance last year paid an average monthly
out-of-pocket cost of $38.50. It also said it provides patients financial

Often, branded and generic companies resolve the litigation with the
generic drugmakers agreeing to hold off on launching their lower-price
copies, sometimes for years. “Every settlement involves delay,” said
Michael A. Carrier, a professor at Rutgers Law School who focuses on
antitrust and patent law.

Patent settlements are on the rise, according to the FTC. Though the
generic drugmakers have to wait, they still can benefit by being paid by
the branded companies to stay off the market, or the brand-name drugmaker
giving them rights to sell their generic exclusively for a time before
other copies can enter the market, Mr. Carrier said.

Generic copies of Latuda won’t go on sale until 2023 under the terms of a
deal between the makers of the generics and Latuda’s manufacturer, Sunovion
Pharmaceuticals Inc., the U.S. subsidiary of Sumitomo Dainippon Pharma
<https://quotes.wsj.com/JP/XTKS/4506> Co. of Japan. The companies reached
the deal after Sunovion sued for patent infringement.

Without a generic version of Latuda available, Christina Wagner said she
had to stop taking the drug.

Ms. Wagner, 59 years old, a widow from DeLand, Fla., began taking the drug
for her bipolar disorder in 2015. But she said she had to reach into her
retirement account and get help from her son to afford a copay under her
Medicare health-insurance plan that surpassed $500 some months. In March,
she told her doctor she couldn’t afford it any longer.

Ms. Wagner said her doctor prescribed other medications but hasn’t found an
effective alternative to Latuda, which helped regulate her mood swings.

“Latuda got me to where I could function,” Ms. Wagner said. “I would
happily go on it again if there was a generic.”

A spokesman for Amneal Pharmaceuticals <https://quotes.wsj.com/AMRX>
Inc., which
applied for approval for a generic version of Latuda in 2014, cited
litigation for its delay and said its generic is likely to be launched in a
few years. Other companies declined to comment or didn’t respond to
requests for comment.

Sunovion said a monthly prescription for most patients costs less than
$8.50 and the company offers financial help to patients.

The Cleveland Clinic estimates it would have saved $187,651 this year, or
about 25% of its spending, if it could purchase a generic version of
transplant drug Zortress, said Jeff Rosner, senior director of pharmacy
sourcing. Novartis prices a monthly .75-milligram dosage at $1,582.

A generic version of Zortress, from Hikma Pharmaceuticals
<https://quotes.wsj.com/HKMPY> PLC, was approved last year, but it won’t be
launched until March, because Hikma had lost a patent-infringement lawsuit
filed by Novartis, according to representatives of Novartis and Hikma.

Novartis said patents play an important role in developing treatments and
that it believes in defending its intellectual-property rights.

Write to Jared S. Hopkins at jared.hopkins at wsj.com

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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